KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR FOR FACE AND BODY BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR FOR FACE AND BODY BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-595-01
Set ID 87496037-36ca-4c5f-973f-46626cf4096e
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredient

    Titanium dioxide 11%

  • Purpose

    Sunscreen

  • INDICATIONS & USAGE

    - helps prevent sunburn

    - if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only

  • Do not use

    on damaged or broken skin

  • When using this product

    keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if

    rash occurs

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    ● shake well before use

    ● apply liberally 15 minutes before sun exposure

    ● reapply:

      ● after 80 minutes of swimming or sweating

      ● immediately after towel drying

      ● at least every 2 hours

    ● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use asunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

      ● limit time in the sun, especially from 10 a.m. – 2 p.m.

      ● wear long-sleeved shirts, pants, hats, and sunglasses

    ● children under 6 months of age: Ask a doctor

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    water, dimethicone, isododecane, c12-15 alkyl benzoate, talc, alcohol denat., undecane, propanediol, styrene/acrylates copolymer, butyloctyl salicylate, phenethyl benzoate, triethylhexanoin, isohexadecane, tridecane, dimethicone/PEG-10/15 crosspolymer, PEG-9 polydimethylsiloxyethyl dimethicone, aluminum hydroxide, aluminum stearate, phenoxyethanol, stearic acid, lycium barbarum fruit extract, sodium chloride, caprylyl glycol, PEG-8 laurate, alumina, polyhydroxystearic acid, disteardimonium hectorite, propylene carbonate, tocopherol, benzoic acid, PEG-9

  • Questions or comments?

    Call toll free 1-800-946-4453

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR FOR FACE AND BODY BROAD SPECTRUM SPF 50 SUNSCREEN 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-595
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE110 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-595-01150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2013
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(49967-595)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458manufacture(49967-595)

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